A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion (COMINO)
Macular Edema, Central Retinal Vein Occlusion, Hemiretinal Vein Occlusion
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring CRVO, HRVO
Eligibility Criteria
Inclusion Criteria:
- Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), diagnosed no longer than 4 months prior to the screening visit
- Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent)
- Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
Exclusion Criteria:
- Any major illness or major surgical procedure within 1 month before screening
- Uncontrolled blood pressure
- Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
- Pregnant or breastfeeding, or intending to become pregnant during the study
Ocular Exclusion Criteria for Study Eye:
- History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
- Macular laser (focal/grid) in the study eye at any time prior to Day 1
- Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
- Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
- Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy
- Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
Ocular Exclusion Criteria for Both Eyes:
- Prior IVT administration of faricimab in either eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
Sites / Locations
- Barnet Dulaney Perkins Eye Center
- Retinal Research Institute, LLC
- Retina Associates Southwest PC
- Retinal Diagnostic Center
- The Retina Partners
- Retina Consultants of Orange County
- Northern California Retina Vitreous Associates
- East Bay Retina Consultants
- California Eye Specialists Medical group Inc.
- Retina Consultants, San Diego
- West Coast Retina Medical Group
- Retina Consultants of Southern Colorado PC
- Colorado Retina Associates, PC
- Retina Group of New England
- Advanced Research
- Rand Eye
- Florida Eye Associates
- Fort Lauderdale Eye Institute
- Retina Vitreous Assoc of FL
- Retina Associates of Florida, LLC
- Southeast Retina Center
- Georgia Retina PC
- Retina Consultants of Hawaii
- Northwestern Medical Group/Northwestern University
- Retina Associated Ltd
- University Retina and Macula Associates, PC
- Prairie Retina Center
- Retina Associates
- Johns Hopkins Med; Wilmer Eye Inst
- Retina Group of Washington
- Cumberland Valley Retina PC
- Assoc Retinal Consultants PC
- VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
- Midwest Vision Research Foundation
- Sierra Eye Associates
- Long Is. Vitreoretinal Consult
- Retina Vit Surgeons/Central NY
- Retina Assoc of Western NY
- Cincinnati Eye Institute
- Retina Northwest
- Cascade Medical Research Institute LLC
- Mid Atlantic Retina - Wills Eye Hospital
- Charleston Neuroscience Institute
- Palmetto Retina Center
- Black Hills Eye Institute
- Charles Retina Institute
- Tennessee Retina PC
- Retina Res Institute of Texas
- Austin Retina Associates
- Austin Clinical Research LLC
- Retina & Vitreous of Texas
- Texas Retina Associates
- Retina Consultants of Texas
- Strategic Clinical Research Group, LLC
- Retina Associates of Utah, PLLC
- Piedmont Eye Center
- West Virginia University Eye Institute
- Fundacion Zambrano
- Centro Oftalmológico Dr. Charles S.A.
- Oftalmos
- Hospital Italiano; Ophtalmology
- Buenos Aires Mácula
- Oftar
- Centro Oftalmólogos Especialistas
- Grupo Laser Vision
- Organizacion Medica de Investigacion
- Eyeclinic Albury Wodonga
- Strathfield Retina Clinic
- Save Sight Institute
- Sydney Retina Clinic and Day Surgery
- Centre For Eye Research Australia
- Retina Specialists Victoria
- The Lions Eye Institute
- LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
- Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
- Hospital de Olhos de Aparecida - HOA
- Hospital das Clinicas - UFRGS
- Botelho Hospital da Visao
- Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
- Hosp de Olhos de Sorocaba
- Beijing Hospital of Ministry of Health
- The Second Hospital of Jilin University
- West China Hospital, Sichuan University
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- The 2nd Affiliated Hospital of Harbin Medical University
- Shanghai Tenth People's Hospital
- Shanghai First People's Hospital
- He Eye Specialist Shenyang Hospital
- The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
- Tianjin Eye Hospital
- Tianjin Medical University Eye Hospital
- Eye Hospital, Wenzhou Medical University
- Renmin Hospital of Wuhan University
- Henan Provincial Eye Hosptial
- General Teaching Hospital Prague; Ophthalmology clinic
- AXON Clinical
- Chi De Creteil; Ophtalmologie
- Hopital Lariboisiere; Ophtalmologie
- Centre Ophtalmologique; Imagerie et laser
- Centres Ophtalmologique St Exupéry; Ophtalmologie
- Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
- Universitätsklinikum Freiburg, Klinik für Augenheilkunde
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
- Queen Mary Hospital; Department of Ophthalmology
- Hong Kong Eye Hospital; CUHK Eye Centre
- Bajcsy-Zsilinszky Hospital
- Budapest Retina Associates Kft.
- Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
- Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
- Zala Megyei Kórház; SZEMESZET
- Rambam Medical Center; Opthalmology
- Hadassah MC; Ophtalmology
- Rabin MC; Ophtalmology
- Kaplan Medical Center; Ophtalmology
- Tel Aviv Sourasky MC; Ophtalmology
- Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
- Irccs Ospedale San Raffaele;U.O. Oculistica
- Sugita Eye Hospital
- Nagoya University Hospital
- Nagoya City University Hospital
- Aichi Medical University Hospital
- Toho University Sakura Medical Center
- Hayashi Eye Hospital
- Kurume University Hospital
- Fukushima Medical University Hospital
- Asahikawa Medical University Hospital
- Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
- Hyogo Medical University Hospital
- Kozawa eye hospital and diabetes center
- Kagawa University Hospital
- Kagoshima University Hospital
- Mie University Hospital
- Shinshu University Hospital
- Osaka Metropolitan University Hospital
- Kansai Medical University Medical Center
- Tokyo Women's Medical University Hospital
- Tokyo Medical University Hachioji Medical Center
- Pusan National University Hospital
- Yeungnam University Medical Center
- Seoul National University Bundang Hospital
- Kyung Hee University Hospital
- Seoul National University Hospital
- Asan Medical Center
- Kim's Eye Hospital
- Samsung Medical Center
- Szpital sw. Lukasza
- OFTALMIKA Sp. z o.o
- Specjalistyczny O?rodek Okulistyczny Oculomedica
- Szpital Specjalistyczny nr 1; Oddzial Okulistyki
- Dobry Wzrok Sp Z O O
- Optimum Profesorskie Centrum Okulistyki
- Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
- Gabinet Okulistyczny Prof Edward Wylegala
- SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
- Centrum Medyczne Dietla 19 Sp. Z O.O.
- MT Medic Krosno
- O?rodek Chirurgii Oka Prof. Zagórskiego Na??czów
- Centrum Medyczne Pulawska SP. z o.o.
- Lens Clinic
- Caminomed
- Centrum Zdrowia MDM
- SPEKTRUM Osrodek Okulistyki Klinicznej
- Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
- Espaco Medico Coimbra
- Hospital de Santa Maria; Servico de Oftalmologia
- Clinic Optimed
- Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
- FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
- 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology
- Medical Military Academy n.a S.M.Kirov
- Singapore Eye Research Institute
- Tan Tock Seng Hospital; Ophthalmology Department
- Hospital Universitario de Bellvitge
- Hospital General de Catalunya
- Hospital Universitario Puerta de Hierro
- Complejo Hospitalario de Navarra; Servicio de oftalmologia
- Centro de Oftalmologia Barraquer; Servicio Oftalmologia
- Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
- Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
- Hospital Universitario Rio Hortega; Servicio de Oftalmologia
- Changhua Christian Hospital; Department of Ophthalmology
- Taipei Veterans General Hospital; Ophthalmology
- Chang Gung Medical Foundation - Linkou; Ophthalmology
- Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
- Birmingham Midland Eye Centre
- Opthalmology Research Office
- Bristol Eye Hospital;Retinal Treatment and Research Unit
- University Hospital of Wales
- St James University Hospital
- Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
- Central Middlesex Hospital
- Maidstone and Tunbridge Wells NHS Trust
- Royal Victoria Infirmary
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).